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NCT05878405 Clinical Trial

Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer

Malignant Solid Neoplasm Clinical Trial

Official title:
Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05878405
Other study ID # 22-007588
Secondary ID NCI-2023-0354222
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 30, 2023
Est. completion date June 2025

Study information
Verified date March 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Active cancer diagnosis - Admitted to the inpatient setting - Pain related to oral mucositis - Experiencing oropharyngeal pain - Able to provide informed consent Exclusion Criteria: - Pediatric age (under 18 years old) - Pregnant or nursing women - Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
Given PO
• Methylene Blue Oral Rinse
Given PO

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in oral pain Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline. Baseline, 3 days
Secondary Change in the amount of oral intake Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output Baseline, 3 days
Secondary Change in the amount of daily requirements of oral morphine equivalents Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output Baseline, 3 days
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